By Professors Shoshy Altuvia and Retsef Levi
After more than a year of unprecedented societal disruption across the world caused by the COVID-19 global pandemic, hopes to regain back some sense of ‘old’ normal are emerging in light of the remarkably rapid development of efficient vaccines against the virus, that protect the populations with the greatest risk of serious illness and fatality. However, the recent decision of the U.S. Federal Drug Administration (FDA) to grant the Pfizer’s vaccine emergency use authorization (EUA) for children ages 12-15, raises important public health and ethical questions related to children’s vaccination.
We argue that vaccinating children at this point in time is simply wrong. Children are at very low risk from COVID-19 and the vaccines are still defined as ‘under investigation drug’ with extremely sparse available data related to efficacy and safety in children. Moreover, accumulating data regarding side effects in the age group of 16-24 indicate that the vaccines may be deleterious to children and young adults. Thus, the intention to vaccinate children deviates from the fundamental principle of medicine to ‘first do no harm’. It is also unethically and unwisely creating global inequity.
Evidence from Israel, the country with the world-highest vaccination rate, suggests that the vaccines are indeed very effective, over 95%, in preventing serious illness and death. After vaccinating well over 60% of adults and over 90% of the high-risk population, infection rates in Israel have dramatically plummeted to near zero, even without vaccination of young children.
Nevertheless, Israel just started a campaign to vaccinate children ages 12-15 and so did the US. Other countries relatively advanced in their vaccination rollout efforts, like the UK, will soon have to debate this very same issue, particularly with children already back to full in-person schooling.
When considering children vaccination against COVID-19, it is important to understand the nature of an EUA that should not be confused with an FDA approval. The FDA approval process of drugs including new vaccines usually lasts several years of clinical trials to verify that the benefit outweighs the risks. Indeed, the phase 3 clinical trials of the COVID-19 vaccines are expected to end around 2022 or 2023. The EUA, on the other hand, is a unique expedited process defined under the Federal Food, Drug, and Cosmetic Act, specifically for emergency situations, where there is a life-threatening disease with no adequate treatment.
Indeed, the high risk of serious illness and fatality that the COVID-19 virus poses to certain populations, specifically, people over 65 and those with certain comorbidities, strongly supports the use of EUA for immediate vaccination of these populations, as it undisputedly will save many lives! However, data from around the world provides mounting evidence that the risk to children is extremely low, with fatality risk 1300-8700 lower than the risk to an individual over 65. In fact, most cases in children are asymptomatic or relatively mild, and even in rare cases of more serious complications, timely treatment is likely to prevent any long-term residual impact, especially in children with no background health issues. Thus, vaccinating children under emergency use authorization will grossly violate the essence and the spirit of this regulatory process.
The safety concerns are not merely theoretical. According to the CDC and other studies, the COVID-19 vaccines seem to have 5-10-fold higher rate of severe allergic reactions. Even more concerning are recent reports regarding the occurrence of acute heart inflammation, particularly within young adults and adolescents. A report by the Israeli Ministry of Health stipulated a risk of experiencing myocarditis, a serious and life-threatening vaccine-associated heart inflammation, in 1 of 3,000 to 6,000 vaccinated young individuals ages 16-24. This conclusion is supported by a recent article in the journal Pediatrics who reports on similar cases, all associated with the second dose of the Pfizer BioNech COVID-19 vaccine. This is a level of risk significantly higher than the respective risk for healthy children from COVID-19.
Additionally, the current vaccines were developed targeting high-risk old adults and not children. Not only that there is no justification for emergency use of vaccination in children, who have very low risk from the COVID-19 virus, it is evident that more time is needed to optimize them (e.g., dose) for children and better understand the potential long-term safety issues.
Finally, the argument that children should be vaccinated based on public health considerations, or as part of an attempt to reach herd immunity, does not have merit. First, even unvaccinated, children are less likely to be infected and/or infect others. Second, all adults in the US and UK will soon have the option to be vaccinated and thus be protected against serious illness and death, regardless of whether children are vaccinated. Third, there are ample reasons to seriously doubt that achieving herd immunity is feasible nor that it will end the existence of the virus. In particular, having one country almost fully vaccinated does not ensure herd-immunity if other countries are not. This also raises an ethical issue regarding the intention to pursue vaccination of extremely low risk children in one country, while other countries still struggle with vaccine supply for high-risk adult populations.
In summary, the EUA granted to COVID-19 vaccines will save many. However, until obtaining further data regarding the risk and benefits of children’s vaccination, we should “leave the kids alone!”
Prof. Shoshy Altuvia, Microbiology and Molecular Genetics, The Hebrew University- Hadassah Medical School, Jerusalem
Prof. Retsef Levi, MIT Sloan School of Management, Cambridge, MA